Onychomycosis Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | January 30, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s). 2. Appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s), as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment. 3. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 2 mm. 4. Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening. 5. In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination or ECG at Screening and/or before the first administration of IP at the discretion of the PI or designee. Participants with mild stable disease may be considered eligible at the discretion of the PI or designee. 6. Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening. Exclusion Criteria: 1. History of allergy to any of the excipients in ATB1651. 2. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1. 3. Underlying physical or psychological medical conditions that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. 4. Unwilling to refrain from the use of nail cosmetics such as clear and/ or colored nail lacquers from the Screening visit until the end of the study. 5. Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening. 6. Diabetes mellitus requiring treatment other than diet and exercise. |
Country | Name | City | State |
---|---|---|---|
New Zealand | New Zealand Clinical Research Christchurch | Christchurch |
Lead Sponsor | Collaborator |
---|---|
AmtixBio Co., Ltd. |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis. | Complete cure rate (defined as 100% clear nail surface area for the target toenail at Week 36 and negative mycological evaluation of the affected great toe after the last dosing). | From screening to end of study treatment up to 252 days | |
Secondary | To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis. | Efficacy of ATB1651 assessed based on Mycological evaluation of the affected great toenail(s) where ATB1651 was applied.
Standardized high-resolution photographs will also be taken and provided to a central reader to confirm the measurements Fungal growth will be measured for the affected great toenail(s) by direct mycological examination using staining (KOH) and culture of the nail scrapings for Trichophyton rubrum, Trichophyton mentagrophytes, Candida albicans, and other fungal species. |
From screening to end of study treatment up to 252 days | |
Secondary | To assess and collect the percentage and severity of adverse events (AEs). | Adverse Events include changes pain, erythema and local irritation, and clinically significant results from physical examinations. AE will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher. | From screening to end of study treatment up to 252 days | |
Secondary | Maximum plasma concentration (Cmax) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by CMAX of ATB1651 | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Time to maximum plasma concentration (Tmax) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 through Tmax of ATB1651 | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Apparent terminal elimination rate constant (?z) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by Apparent terminal elimination rate constant (?z) | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Area under curve (AUC) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by AUC | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Apparent terminal half-life (t 1/2) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by (t 1/2) | Cohort 1, 3 and 5- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Apparent clearance (CL) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by apparent clearance (CL). | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Apparent terminal volume of distribution (VD) | Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by VD | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 | |
Secondary | Plasma ATB1651 trough concentrations (Ctrough) | Pharmacokinetic profile characterized by trough concentrations (Ctrough) of ATB1651 | Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140 |
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